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ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.

ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.

ADAS 3D is indicated to be used only by qualified medical professionals ( cardiologists, radiologists, radiologists, radiologists, or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.

The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias ( e.g., ventricular tachycardia) or risk stratification has not been established.

ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced Magnetic Resonance (MRI) images and Computed Tomography Angiography (CTA) images.

ADAS 3D is designed to process DICOM image databases to enable the calculation, quantification and visualization of 3D cardiac imaging data by displaying and quantifying the levels of enhancement. ADAS 3D also enables the visualization of the shape of the cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard for viewing on other systems, including Electrophysiology (EP) navigation systems.

The provided text describes a 510(k) submission for the ADAS 3D device, which is a software-based image processing tool for post-processing cardiovascular MRI and CTA images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a submission involving clarifications to Indications for Use and Precautions sections of a previously cleared device (ADAS 3D, K191125). It explicitly states: "The ADAS 3D device that is the subject of this Special 510(k) is identical to the ADAS 3D device cleared under (K191125). Only clarifications to the Indications for Use and Precautions sections have been made... These labelling changes do not impact the safety or effectiveness of the device."

This means the current document does not contain a new study demonstrating the device's performance against acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device (K191125), implying that any performance studies were conducted and reviewed during the clearance of K191125.

Therefore, the following answers are based on what might be expected for a device like this, or what we can infer from the description of ADAS 3D's functionalities and the acceptance criteria mentioned for its 3D Corridors Module. The document does not explicitly detail a performance study for K210850 because it's a special 510(k) primarily for labeling changes.

1. Table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria for the overall device's performance in K210850, as this submission focuses on labeling changes.

However, for the "3D Corridors Module," the document defines the criteria for what the algorithm must identify as a 3D Corridor. If this were a performance study, these would be the ground truth definitions that the algorithm's output would be compared against. The document does not provide "reported device performance" against these criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document for K210850 does not describe a new performance study, thus no test set sample size or data provenance is provided. Any such information would have been part of the original K191125 submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No new performance study in K210850, so this information is not provided. The definitions for the "3D Corridors Module" are given algorithmically, not as expert-established ground truth from a study within this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No new performance study in K210850, so this information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study for K210850. The device is a post-processing tool intended to "support the visualization and analysis" and "support qualified medical professionals for clinical decision making," implying assistance, but no comparative effectiveness study with human readers is detailed here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This document does not describe a standalone performance study for K210850. The device itself is software-only (standalone software application), but performance evaluation of its outputs against a ground truth is not presented here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "3D Corridors Module," the ground truth definition is algorithmic based on specific criteria (BZ region, HT region, CS region, minimum length). If a performance study were done, the algorithm's output would be compared against these predefined algorithmic criteria or against expert delineations following these criteria. The document does not specify which type of ground truth was used in any prior studies, or if such studies specifically used expert consensus, pathology, or outcomes data to validate the clinical significance of these algorithmic definitions. Indeed, the Indications for Use state, "The clinical significance of using ADAS 3D to identify arrhythmia substrates... has not been established."

8. The sample size for the training set

No details on training set size are provided in K210850.

9. How the ground truth for the training set was established

No details on training set ground truth establishment are provided in K210850.

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